The letter addressed to Radcliff Consultants, an agent for the company, refers to a review of the company's websites whereby it determined that its BrowRevive Serum, Adonia LegTone Serum, and Athena Nightly Renewal Cream amongst other products were being promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act.
The Administration’s main concern is that Greek Island Labs products are being marketed in such a way that they should be promoted as drugs under section 201.
“The claims on your websites indicate that these products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body, rendering them drugs under the Act.”
The marketing claims highlighted by the FDA includes; “Organic Lavender … Human clinical studies have reported that lavender essential oil may be beneficial in … alopecia (hair loss) and as an antibacterial agent" to which the administration stated "are not generally recognized among qualified experts as safe and effective for the above referenced uses."
As a result of its findings, the FDA has requested that company representatives contact the FDA to outline the specific action it intends to take to ensure that the products comply with the Federal Food Drug and Cosmetic Act within 15 days.
“We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.”
FDA crack down on cosmetic companies
The FDA regularly raps cosmetics companies over marketing claims associated with cosmetic and personal care products, and is particularly vigilant over anti-aging claims.
Only last week, it sent a warning letter to L’Oreal over marketing terms relating to skin care products sold under its Lancôme brand in the United States.
In this complaint the organization cited concerns of 11 different skin care products marketed under the Génifique, Absolue and Rénergie brand names on the company’s US-dedicated website portal.